China is Expected to Become the Fifth Largest Drug Market in the World by 2010.DUBLIN Dublin, city, Republic of Ireland Dublin, Irish Baile Átha Cliath, county borough (1991 pop. 915,516), Leinster, capital of the Republic of Ireland, on Dublin Bay at the mouth of the Liffey River. , Ireland Ireland, Irish Eire (âr`ə) [to it are related the poetic Erin and perhaps the Latin Hibernia], island, 32,598 sq mi (84,429 sq km), second largest of the British Isles. -- Research and Markets (http://www.researchandmarkets.com/reports/c51731) has announced the addition of China Pharmaceutical Guidebook Series (1) (2nd Edition) Latest Chinese Chinese, subfamily of the Sino-Tibetan family of languages (see Sino-Tibetan languages), which is also sometimes grouped with the Tai, or Thai, languages in a Sinitic subfamily of the Sino-Tibetan language stock. Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies 2007 to their offering. China possesses a fourth of the population in the world and has one of the largest drug markets round the world. By 2006, sales on the Chinese drug market have reached $12 billion dollars, an increase of 3.8 fold over 1998 level. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate of 20-25 percent per annum Per annum Yearly. in next five years. China is expected to become the fifth largest drug market in the world by 2010. Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2006, sales of imported drugs have shared one fifth on the Chinese drug market. As China joins the World Trade Organization (WTO See World Trade Organization. ) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug markets and seize seize v. To exhibit symptoms of seizure activity, usually with convulsions. a larger part of such a drug market. To enter such a lucrative drug market, the first obstacle faced by overseas pharmaceutical manufacturers and producers is how to file the application for their imported drug registration with Chinese pharmaceutical authorities. The latest "Measures for the Administration of Drug Registration" have entered into force since May 1, 2005. These "Measures" provide detailed requirements and procedures of application and approval for imported drug registration. Under such circumstance Circumstance or circumstances can refer to:
- Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies - Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs - Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products - Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Traditional Chinese Medicines Traditional Chinese Medicine Definition Traditional Chinese medicine (TCM) is an ancient and still very vital holistic system of health and healing, based on the notion of harmony and balance, and employing the ideas of moderation and prevention. and Natural Medicines In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find out every answer that they will meet during the process of application and approval for their imported drug registration. Since the publication of China Pharmaceutical Guidebook Series, many executives from overseas pharmaceutical companies have paid attention to this guidebook series, and expect to acquire further detailed information about Chinese regulations for imported drug registration, so that the author completed the second edition in early 2007 to contribute this second edition of China Pharmaceutical Guidebook Series to overseas pharmaceutical companies. Report Highlights - An overview of the main responsibilities and organization structure of the SFDA SFDA State Food and Drug Administration (China) SFDA Saudi Food & Drug Authority (The State Food and Drug Administration The State Food and Drug Administration (SFDA Simplified Chinese: 国家食品药品监督管理局) is founded on the basis of the State Drug Administration. ) that is the current Chinese pharmaceutical authority at the central level, and takes responsible for application and approval for imported drug registration. - The comprehensive regulations for imported drug registration in China, from the classification of drugs, definitions relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the application for imported drug registration, the application and approval for imported drugs and repackaging of imported drugs, the supplementary application and re-registration for imported drugs, the clinical investigation for application of imported drug registration to the time limits in drug registration. - The procedures of application and approval for imported drug registration, including the procedures of the initial application and approval for imported drugs, the supplementary application and approval for imported drugs, and the application and approval for clinical trials relating to imported drugs. - The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their pharmaceuticals registration in China. Who should buy this report? - Companies wishing to enter a lucrative drug market in China. - Companies interested in understanding the latest Chinese regulations on application and approval for imported drug registration. Topics Covered Preface pref·ace n. 1. a. A preliminary statement or essay introducing a book that explains its scope, intention, or background and is usually written by the author. b. An introductory section, as of a speech. 2. Chapter 1. Introduction Chapter 2.The State Food and Drug Administration in China 2.1. SFDA's Main Responsibilities 2.2. SFDA's Organization Structure Chapter 3.General Regulations on Application and Approval for Imported Drug Registration 3.1. Classification of Drugs 3.2. Definitions 3.3. General Regulations on Application and Approval for Imported Drug Registration 3.3.1. Application and Approval for Imported Drug 3.3.2. Application and Approval for Repackaging of Imported Drug 3.3.3. Supplementary Application 3.3.4. Re-registration 3.3.5. Clinical Investigation 3.3.5.1. Preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. investigation 3.3.5.2. Clinical Trials 3.3.6. Time Limits in Drug Registration Chapter 4. Application and Approval Procedures for Imported Drug Registration 4.1.Application and Approval Procedure for Imported Drugs 4.2.Supplementary Application and Approval Procedure for Imported Drugs 4.3.Application and Approval Procedure for Clinical Trials Chapter 5. Conclusion Chapter 6. Appendices ap·pen·di·ces n. A plural of appendix. 6.1. References 6.2. Resources 6.3. Author's Biography biography, reconstruction in print or on film, of the lives of real men and women. Together with autobiography—an individual's interpretation of his own life—it shares a venerable tradition, meeting the demands of different audiences through the ages. For more information visit http://www.researchandmarkets.com/reports/c51731 |
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